Access Versus Conventional Femoral ure: Outcome and Resource Effectiveness in a Daily Routine. The RAPTOR-Trial

Transcription

1 Radial Access Versus Conventional Femoral Puncture: ure: Outcome and Resource Effectiveness in a Daily Routine. The RAPTOR-Trial Trial Tim G. Schäufele, Jean-Philippe Grunebaum, Beate Lippe, Thomas Breidenbach and Eberhard von Hodenberg Department of Cardiology

2 Presenter Disclosures Tim G. Schäufele, MD Radial Access Versus Conventional Femoral Puncture: Outcome and Resource Effectiveness in a Daily Routine: The RAPTOR-Trial Financial Disclosures There are no Financial Conflicts to Disclose Unapproved Uses/Drugs Disclosures There are no unapproved drugs or devices used in this trial

3 Background -Less bleeding complications -Rapid ambulation -More economic use of human and hospital resources -Higher patient comfort -Possible entry site failure -Occurrence of unsuccessful arterial puncture -Higher radiation doses -Longer procedural times -Occlusion and/or spasm of the radial artery

4 Study purpose Is it feasible for an interventional site with operators experienced in femoral access to switch ad hoc to radial access as a routine strategy in a real world population with regard towards -Patient safety -Radiation exposure -Patient comfort -Procedural durations -Staff involvement -Overall effectiveness

5 Methods Study design: Prospective, randomized single center trial to compare radial vs. femoral access in a 1:1 ratio in an unpreselected population Exclusion criteria -Abnormal Allen Test -Planned CABG -ESRD -Pregnancy -Hyperthyroidism Outcome parameters: Interventional -Access site failure -Procedural time -Flouroscopy time -Radiation exposure Peri-/Post interventional -Staff involvement (cath lab) -Staff involvement (ward) -Bleeding complications -Patient satisfaction

6 4/2008-4/2009: 421 patients included 410 evaluated Baseline Characteristics Procedures performed Femoral Radial P Value Femoral Radial P Value Age 66±9 64± Diagnostic only 152 (73.4%) 152 (74.8%) 0.7 Male (%) Hight (cm) 169± ± PCI 55 (27%) 51 (25%) 0.7 CABG 12 (6%) 5 (3%) 0.09 BMI 28±4 28±4 1 Hypertension (%) Known CAD (%) Access Failure Ambulatory Treatment 8 (3.4%) 8 (3.6%) (21%) 53 (26%) 0.5

7 Procedural Durations Femoral Radial Delta P Value Puncture 0.9± ±3 2.9±1,6 <0.01 Coronary Angiography Coronary Angiography + PCI PCI withsheath Exchange 8.4±4 10.9±6 1.8±0.3 < ± ± ± ± PCI without Sheath Exchange 16.3±13 21±9 4.7±4 0.3 All values given in minutes; p<0.05 considered statistically significant

8 Radiation Times Femoral Radial Delta P Value RT Diagnostics 4.4±5 6.4±5 2 <0.01 RT-PCI RCA 8.6±8 6.4±5 2.2±3 0.7 RT-PCI LCA 5.2±3 7±4 1.8±1 0.8 RT = Radiation Time; RCA = right coronary artery; LCA = left coronary artery All values given in minutes; p<0.05 considered statistically significant

9 Radiation Dose (Dose Area Product) Femoral Radial Delta P Value RD Diagnostics 22.6± ±16 7.1±1 <0.01 RD-PCI RCA 27.1± ±23 0.7±4 0.5 RD-PCI LCA 31.9± ±17 5.8± RD = Radiation Dose; RCA = right coronary artery; LCA = left coronary artery All values given in Gycm²; p<0.05 considered statistically significant

10 Involvement of Staff Diagnostics Manual Compression of Access Site Handling in Cath Lab Time Nurse Spent with Patient Femoral 13± ±5 45.2±27 Radial 0.6±3 17.3± ±18 Delta 12.4±37 3±7 13.4±9 P Value < Involvement of Staff Interventions Manual Compression of Access Site Handling in Cath Lab Time Nurse Spent with Patient Femoral 11.6±9 15.7±6 64.4±33 Radial 0±0 16.6±4 30.6±15 Delta ±2 34±18 P Value < <0.01 All values given in minutes; p<0.05 considered statistically significant

11 Economical Impact of Staff Involvement Time Diagnostics + Sheath Removal Time Diagnostics + PCI + Sheath Removal Femoral 72.5± ±36 Radial 54.6± ±12 Time Saved by Radial Access 17.9± ±24 P Value <0.01 <0.01 All values given in minutes; p<0.05 considered statistically significant 3000 procedures/year with 1000 PCI Δ staff involvement = 1383 hours = 36.4 weeks

12 Learning progress for radial access 1. Quartile 4. Quartile P Value Operator # 1 Operator # 2 Operator # 3 Procedure Time 11.9±9 10.3±3 0.6 Radiation Time 10.7±11 6.1± Procedure Time 10.6±6 13.3±7 0.3 Radiation Time 6.9±5 6±4 0.6 Procedure Time 8.9±6 11.4±6 0.1 Radiation Time 6.8±5 7.4±5 0.6 Values are given in minutes ± SD

13 Adverse events Femoral Radial P Value Hematoma 19 4 <0.01 Pseudo Aneurysm 2 0 N/A AV-Fistula 1 0 N/A Pain at Back/Puncture Site 43 8 <0.01 Puncture Site Bleedings 18 4 <0.01 Vagal Reactions 19 0 <0.01

14 Acces Site Failure Femoral Radial P Value Access Site Failure 8 8 N/A Femoral Group Unsuccessful femoral puncture (n=4) Kinking of the iliac artery (n=3) Acute bleeding at the puncture site (n=1) Radial Group Unsuccessful radial puncture (n=4) Tortuosities (n=3) Spasm (n=1)

15 Quality of Life No Differences for -No differences in -Tolerance of arterial puncture -Tolerance of procedure itself -Tolerance of procedural duration Advantage towards Radial Access for -Pain due to Compression Device -Preference of Alternative Access Route

16 Summary Summary -Switching to radial access leads to only mild procedural prolongation when diagnostic coronary angiography is performed -Differences in procedural times are no longer significant for PCI -Radiation time and dose are extended for diagnostic angiography, but are similar for interventions -Using radial approach leads to a more economic use of resources -The procedure is safe and well tolerated by patients

17 Conclusion Conclusion The RAPTOR Trial demonstrates that experienced invasive cardiologists can easily and rapidly shift their practice towards radial access. The results of the present trial should therefore encourage interested centers to switch from femoral to radial access as a routine strategy.

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